Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma

- The safe dose of dexamethasone is already known. The dose of bortezomib and lenalidomide
will be increased during the study until the best and safest amount (or dose) is
identified. The participant's dose of the study drugs will depend on when they enter the
study.

- In this study each cycle will be 21 days and participants will begin the study
medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily
for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1,
2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient
treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study
medication will be given.

- During the course of the study treatment, tests and procedures will be performed at
designated time periods. This includes; medical history updates, physical/neurological
examinations, skeletal survey (x-rays or scan), blood samples, optional bone marrow
aspiration/tissue biopsy, urine samples, 12-lead ECG, and MRI/CT scan (if needed).

- It is expected that study participants will receive study treatment for 8 cycles (168
days). If the participant completes the first 8 cycles of the study, has stable or
responding disease and has not experienced bad side effects, they will be allowed to
continue treatment on a maintenance schedule, detailed in the protocol, at the study
doctor's discretion.

Inclusion Criteria:

- Diagnosed with multiple myeloma based on standard diagnostic criteria or by the new
International Myeloma Foundation 2003 Diagnostic Criteria

- Must not have been previously treated with any prior systemic therapy for the
treatment of multiple myeloma

- Negative serum or urine pregnancy test

- Age 18 years or older

- Karnofsky performance status of greater or equal to 60

Exclusion Criteria:

- Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14
days before enrollment

- Renal insufficiency (serum creatinine >2.5 mg/dL)

- Evidence of mucosal or internal bleeding and/or platelet refractory

- ANC (absolute neutrophil count)< 1000 cells/mm3

- Hemoglobin < 8.0 g/dL

- AST (aspartate aminotransferase) or ALT (alanine aminotransferase) greater than or
equal to 2 x ULN (upper limit of normal)

- Concomitant therapy medications that include corticosteroids

- Myocardial infarction within 6 months prior to enrollment according to NYHA (New York
Heart Association) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities

- Clinically relevant active infection or serious co-morbid medical conditions

- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in
situ cervical, breast or prostate cancer

- Pregnant or breast-feeding

- Serious medical or psychiatric illness likely to interfere with participation in study

- Uncontrolled diabetes mellitus

- Hypersensitivity to acyclovir or similar anti-viral drug

- POEMS syndrome

- Known HIV infection

- Known active hepatitis B or C viral infection

- Known intolerance to steroid therapy